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FDA 510(k) Application Details - K151874
Device Classification Name
Ventilatory Effort Recorder
More FDA Info for this Device
510(K) Number
K151874
Device Name
Ventilatory Effort Recorder
Applicant
Salter Labs
2365 Camino Vida Roble
Carlsbad, CA 92011 US
Other 510(k) Applications for this Company
Contact
Mara Caler
Other 510(k) Applications for this Contact
Regulation Number
868.2375
More FDA Info for this Regulation Number
Classification Product Code
MNR
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
07/09/2015
Decision Date
04/15/2016
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
AN - Anesthesiology
Review Advisory Committee
AN - Anesthesiology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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